Neuros Medical

Neuros Medical is a bioelectric technology company that has developed the Altius System, a patient-controlled, on-demand device designed to alleviate chronic post-amputation pain. The Altius System incorporates Neuros' patented On-Demand Bioelectric Nerve Block technology, which delivers a high-frequency electrical signal to sensory nerves in the peripheral nervous system, effectively blocking the transmission of pain signals.

The system comprises a nerve cuff electrode placed around the affected nerve and an implantable pulse generator (IPG). Patients can initiate a 30-minute treatment session as needed to achieve targeted pain relief. Neuros' technology offers a novel approach to managing chronic post-amputation pain, a significant unmet medical need, as existing treatment options are primarily limited to opioids and gabapentinoids.

In June 2021, the Altius System received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its potential to provide more effective treatment for chronic intractable pain in adult lower limb amputees. The company completed enrollment for its pivotal QUEST (High-FreQUEncy Nerve Block for PoST-Amputation Pain) study in Fall 2021, a 180-subject, randomized, double-blinded, active sham-controlled clinical trial conducted under an Investigational Device Exemption (IDE).

In June 2022, Neuros Medical announced the completion of the QUEST Pivotal Trial's 90-day primary endpoints, with plans to submit the Altius System's Pre-Market Approval application to the FDA after the study is unblinded in Fall 2022. The company expanded its operations with a 10,000 square foot facility in Aliso Viejo, CA, certified by the European Notified Body, BSI, to International Standards Organization (ISO) 13485:2016 standards.